ASU Biological Safety Manual - Arizona State University

ASU Biological Safety Manual

December 2022 Questions? Email biosafety@asu.edu or call 480-965-1823

Page 1

Foreword

The Biological Safety Manual (or Biosafety Manual) has been adopted by Arizona State University to be a resource for information, guidelines, policies, and procedures that will enable safe research and to help eliminate, or reduce, the potential for exposure to biohazards. The Department of Environmental Health and Safety (EHS) developed this manual to help ensure compliance with the following federal, state, and local regulations and guidance materials:

? 18 United States Code ? 175b ? 29 Code of Federal Regulations ? 1910.1030 ? 42 Code of Federal Regulations ? 1003 ? 42 Code of Federal Regulations ? 71.54 ? 42 Code of Federal Regulations ? 72-73 ? 49 Code of Federal Regulations ? 171-180 ? 7 Code of Federal Regulations ? 331 ? 9 Code of Federal Regulations ? 121 ? Arizona Administrative Code, Article 14, Biohazardous Medical Waste and Discarded Drugs ? Arthropod Containment Guidelines, Version 3.2. ? Centers for Disease Control and Prevention and National Institutes of Health, "Biosafety in

Microbiological and Biomedical Laboratories, 6th Edition."

? Department of Health and Human Services, "Guide for the Care and Use of Laboratory

Animals, 8th edition."

? National Institutes of Health, "Guidelines for Research Involving Recombinant or Synthetic

Nucleic Acid Molecules"

? Public Act 107-188, HR3448 ? United States Department of Agriculture, or USDA permitting requirements

The ASU Biosafety Manual provides a compilation of suggested work practices, protocols, and systems to work safely at ASU. The ASU Biosafety Manual should not be considered the only reference for health and safety concerns. It is intended that the principal investigator and supervisory personnel will supplement this information with instruction and guidance regarding specific practices and procedures unique to the work being done in their areas by completing a labspecific biosafety manual and including all relevant documentation available to laboratory users. In addition, EHS is always available to address health and safety concerns. The ASU Biosafety Manual is reviewed at least annually by EHS and the Institutional Biosafety Committee and was last approved on December 19, 2022.

December 2022 Questions? Email biosafety@asu.edu or call 480-965-1823

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Signatures:

David Gillum (Dec 19, 2022 17:00 MST)

David Gillum, Assistant Vice President Chief Safety Officer and CDC Responsible Official Environmental Health and Safety

Debra Murphy

Debra Murphy (Dec 20, 2022 17:35 MST)

Debra Murphy, Director Institutional Official Office of Research Integrity and Assurance

Bertram Jacobs PhD, Professor Chair, Institutional Biosafety Committee Center for Immunotherapy, Vaccines and Virotherapy

Giorgio Scarpellini

Giorgio Scarpellini (Dec 21, 2022 12:49 MST)

Giorgio Scarpellini, MS Institutional Biosafety Officer Sr. Safety Partner, Biosafety and Biosecurity Environmental Health and Safety

Gregory L. Powell

Gregory L. Powell (Dec 22, 2022 08:59 MST)

Gregory L. Powell, PhD Animal Biosafety Officer Sr. Safety Partner, Animal Biosafety Environmental Health and Safety

December 2022 Questions? Email biosafety@asu.edu or call 480-965-1823

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Table of Contents

Foreword...................................................................................................................................... 2

Introduction ................................................................................................................................. 7

Biosafety oversight..................................................................................................................... 8

Roles and responsibilities ......................................................................................................... 9

A.

Arizona State University ............................................................................................. 9

B.

Institutional Biosafety Committee ............................................................................. 9

C.

Biosafety in Animal Use ........................................................................................... 10

D.

Environmental Health and Safety and ASU Biological Safety Officer ................. 10

E.

ASU Employee Health............................................................................................... 11

F.

Principal Investigator................................................................................................ 11

G.

Laboratory personnel ............................................................................................... 13

H.

Responsible Official.................................................................................................. 13

I.

Other organizations .................................................................................................. 14

J.

Visitors, vendors, and contractors.......................................................................... 14

Incident reporting ..................................................................................................................... 15

A.

Reportable incidents and violations ....................................................................... 15

B.

Principal Investigator responsibilities .................................................................... 15

C.

Biological Safety Officer responsibilities ............................................................... 15

D.

Institutional responsibilities .................................................................................... 16

E.

Institutional Official responsibilities ....................................................................... 16

Risk Group classifications....................................................................................................... 17

Biological Safety Levels........................................................................................................... 18

Animal Biological Safety Levels.............................................................................................. 20

Arthropod Containment Levels ............................................................................................... 23

Training for working safely with biohazards ......................................................................... 25

Biohazardous research project registration .......................................................................... 26

A.

Select agents and toxins .......................................................................................... 26

B.

Toxins of biological origin ....................................................................................... 26

C.

Human blood and tissue .......................................................................................... 27

D.

Recombinant and synthetic nucleic acid molecules............................................. 27

E.

Environmental samples ............................................................................................ 27

Controlled substances ............................................................................................................. 28

Animal research project registration ...................................................................................... 30

A.

Vertebrate Animals.................................................................................................... 30

B.

Arthropod Research Project Registration .............................................................. 30

December 2022 Questions? Email biosafety@asu.edu or call 480-965-1823

Page 4

Field research project registration......................................................................... 31

Biohazardous waste ................................................................................................................. 32

Animal waste ............................................................................................................................. 33

Biohazardous waste handling ................................................................................................. 34

Laboratory procedures and equipment.................................................................................. 35

A.

Exposure control ....................................................................................................... 35

B.

Biological safety cabinets, or BSC .......................................................................... 36

C.

Steps for working in a biological safety cabinet.................................................... 39

D.

Certification of the biological safety cabinet ......................................................... 39

E.

Decontamination ....................................................................................................... 40

F.

Decontamination in animal facilities ....................................................................... 42

Animal hazards and exposures............................................................................................... 43

A.

Bites and scratches .................................................................................................. 43

B.

Physical hazards ....................................................................................................... 43

C.

Chemical hazards...................................................................................................... 44

D.

Animal allergies......................................................................................................... 44

E.

Latex gloves and related allergies........................................................................... 45

Zoonoses ................................................................................................................................... 47

A.

Rodents ...................................................................................................................... 47

B.

Gerbils, hamsters, and other small rodents ........................................................... 48

C.

Laboratory rabbits..................................................................................................... 48

D.

Birds ........................................................................................................................... 48

E.

Dogs and cats ............................................................................................................ 49

F.

Fish, corals, and amphibians ................................................................................... 49

G.

Reptiles ...................................................................................................................... 49

H.

Livestock .................................................................................................................... 50

I.

Non-Human Primates, or NHPs ............................................................................... 50

Emergency response procedures........................................................................................... 52

A.

Exposures to biohazards ......................................................................................... 52

B.

Spills of biohazards (including r/sNA molecules) ................................................. 53

C.

Spills of biohazards inside a biological safety cabinet......................................... 53

D.

Small spills (500 ml) of biohazards outside a biological safety cabinet ............. 54

F.

Spill of biohazards in a centrifuge........................................................................... 55

G.

Reporting exposures ................................................................................................ 55

Permits ....................................................................................................................................... 56

A.

CDC Import Permit Program .................................................................................... 56

December 2022 Questions? Email biosafety@asu.edu or call 480-965-1823

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